What you need to know about the 340B OPAIS transition
The Health Resources and Services Administration (HRSA) and the Office of Pharmacy Affairs (OPA) are making updates to the 340B Office of Pharmacy Affairs Information System (340B OPAIS) and are releasing a new registration system, as well as a new pricing system. During preparations for this release, the current system will not be available from mid- August until mid-September.
The new, more secure systems, will be released on two different dates. The release of the new registration system will happen in mid-September, while a date has not yet been set for the release of the new secure pricing system.
There are significant changes that impact Covered Entities’ and may create concerns and confusion, if you are unfamiliar with the registration process and system. Below are some of the enhancements and changes being made to the registration system.
Enhancements & Changes
- You will manage your own 340B record
- The Authorized (AO) and Primary Contact (PC) of a 340B ID must be different individuals
- The AO of each child-site 340B ID must be the same AO as the parent 340B ID
- The PC of each child site 340B ID may be a different PC than the parent 340B ID or other child site 340B IDs
- Only the AO can submit an OPA registration – including addition of sites and contract pharmacies.
- It is the responsibility of the AO to ensure that PCs are eligible to access data
- The AO will review, approve, and submit information on behalf of their organization
- Only the AO and PC can view reports.
In the statement released by HRSA, it was stated that “The registration component of the new 340B OPAIS will modernize the current 340B Database to enhance its functionality and security for both manufacturers and covered entities. This new system will increase the integrity and effective use of 340B stakeholder information.”
If you are not familiar with the registration process or reporting process, these changes may seem overwhelming. To help ease the confusion, HRSA’s website will have educational resources. If you have an emergent 340B Record issue while the system is down, you may call 340B PVP at (888) 340-2787.
If you have any questions, please reach out to us. We are experts in 340B and can answer all your questions.